CMC Development manufacturing
Chemistry Manufacturing & Controls uses Quality by Design to establishing the manufacturing process, potency of product, quality controls, and analytical methods needed to consistently produce the ATMP. Running in parallel with product and clinical development, this work ensures that the therapy can be manufactured reliably, remains stable throughout its lifecycle, and meets regulatory quality requirements. As knowledge of the product grows, manufacturing processes and control strategies are continuously refined to support clinical studies and prepare for future commercialization.
Health Innovation Labs
Sahlgrenska Science Park offers flexible labs and office services at the heart of Gothenburg’s life science ecosystem in the Sahlgrenska area.
Emilie in Toronto – Summer by Design
This June, Emilie Rickardsson Bergqvist participated in Summer by Design 2026 in Toronto, Canada, with support from SCALE. Emilie is a physician from Gothenburg specializing in Clinical Immunology and Transfusion Medicine.
Vera CQ
Vera CQ is founded by colleagues who enjoy working together, every day. With a joyful, collaborative and solution-oriented approach, we provide expert support in GxP, training and audits, across the life science field.
Getinge
Getinge is a global medtech company providing advanced manufacturing, cleanroom, and aseptic processing solutions that support the development and production of ATMPs, including cell and gene therapies.
Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products
This training course is intended for professionals involved in conducting clinical trials with Advanced Therapy Medicinal Products (ATMPs). It complements the ICH-GCP guidelines by addressing specific requirements for clinical trials conducted with ATMP within the EU. This training course is based on the Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products.
Good Manufacturing Practice (GMP) for ATMPs – Practical Application
This training course is designed for individuals who will be involved in the manufacturing or handling of Advanced Therapy Medicinal Products (ATMPs) within a GMP-regulated environment. The course provides practical examples of how Good Manufacturing Practice (GMP) is applied to ATMPs and covers topics including aseptic processing, hand hygiene, cleanroom environments, gowning procedures, good documentation practices, as well as aseptic operations and cleaning in cleanrooms. The training is based on current EU GMP requirements and relevant ATMP-specific guidelines. A basic understanding of GMP, or experience working in a GMP-regulated environment, is advantageous.
AstraZeneca
AstraZeneca is global pharma company with strong connection to Sweden through both big research and manufacturing sites. Their development of ATMPs includes CAR-T and TCR-T treatments, as well as drug delivery platforms. Their research as well as product development is spread out globally with over 80 000 employees over the world.
Laboratory methods for Advanced Therapy Medicinal Products (ATMP)
(BMA123) Ta chansen att lära dig mer om avancerade terapiläkemedel (ATMP). Kursen ger en introduktion till området och fokuserar på arbete enligt Good Manufactureing Practice (GMP) och kvalitetskontroll. Laboratoriemedicinska metoder som används för att säkerställa kvalitet, så som mikrobiologiska tester, tester av viabilitet med mera kommer går igenom. Kursen innehåller praktiska övningar och studiebesök. Föreläsningar på engelska kan förekomma.
GBA Key2Compliance
GBA Key2Compliance offers complete and optimised solutions within Regulatory compliance.
Verigraft
VERIGRAFT uses a proprietary patent-protected technology to make donated tissue resemble the patient’s own. This personalized tissue is tailored to the patient and can be implanted without rejection.
Bioprocessing for the production of advanced biologics using mammalian cells
(CB2120) This course provides a comprehensive introduction to mammalian cell culture and bioprocessing for the development and manufacture of advanced biologics, including monoclonal antibodies, cell therapies, and viral vectors for gene therapy.
From Research to ATMP Treatment – Process Development, Quality Assurance, Regulatory Affairs and Logistics
Take your expertise to the next level with this cutting-edge course in cell and gene therapy (ATMP) development and production. Gain a deep understanding of every step in the process, from designing and implementing standard operating procedures (SOPs) to ensuring product purity and function. Learn how to navigate the transition from pre-GMP to GMP, understand key regulatory requirements, and explore the legal landscape of ATMP products.
CCRM Nordic
CCRM Nordic, based in Gothenburg, Sweden, supports academic, small, and large industrial ATMP developers to translate research and early-stage clinical programs into treatments for patients.